Medical Software Development

What You Will Learn

• 1 Learn the regulatory landscape for medical software including FDA, HIPAA, and international standards.
• 2 Understand medical data standards and interoperability such as HL7, FHIR, and DICOM.
• 3 Apply software design patterns for safety-critical systems in healthcare.
• 4 Analyze risk management processes according to ISO 14971 for medical device software.
• 5 Implement usability engineering and human factors to ensure patient safety.
• 6 Develop quality management systems (QMS) compliant with ISO 13485 for software.
• 7 Perform software verification and validation (V&V) to demonstrate safety and efficacy.
• 8 Design cybersecurity controls for medical devices to protect against threats.
• 9 Manage software maintenance and post-market surveillance in a regulated environment.
• 10 Explore emerging trends: AI in medical devices, cloud computing, and telemedicine.